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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2024 |
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Main ID: |
NCT02879136 |
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Date of registration:
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23/06/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease
TAME-PD |
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Scientific title:
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TAME-PD - Physical Therapy, Atomoxetine and, Methylphenidate, to Enhance Gait and Balance in Parkinson's Disease: A Single Center, Randomized Pilot Study |
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Date of first enrolment:
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December 2016 |
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Target sample size:
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42 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02879136 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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Early Phase 1
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Countries of recruitment
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United States
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Contacts
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Name:
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Shnehal Patel, MD |
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Address:
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Telephone:
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Email:
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patels7@ccf.org |
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Affiliation:
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Name:
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Shnehal Patel |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Cleveland Clinic |
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Name:
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Shnehal Patel, MD |
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Address:
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Telephone:
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Email:
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patels7@ccf.org |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with PD having significant balance or gait disorder with a score =2 in the
Unified Parkinson Disease Rating Scale (UPDRS) 3.10 item 'independent walking but with
substantial gait impairment; not related to off periods' occurring despite
satisfactory motor control by dopaminergic therapy, with a medication regimen unlikely
to change in the next 30 days.
Exclusion Criteria:
- Previous participation in PD-specific PT.
- Presence of signs and symptoms suggestive of atypical parkinsonism.
- Concomitant conditions that may affect significantly the evaluation of balance or
gait, including orthopedic, rheumatologic or other neurological diseases.
- Contraindication for physical therapy
- Comorbidities that contraindicate the use of the methylphenidate or atomoxetine:
history of substance abuse, current severe anxiety, depression or psychosis, epilepsy,
hyperthyroidism, glaucoma, cardiac arrhythmia, history of Tourette syndrome, hepatic
disease, allergy to methylphenidate or atomoxetine.
- Concurrent use of MAO inhibitors, or use in the last two weeks.
- Previous deep brain stimulation procedure.
- Punctuation of 5 in Hoehn and Yard modified scale: 'Wheelchair bound or bedridden
unless aided'.
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson's Disease, Idiopathic
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Intervention(s)
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Drug: Atomoxetine
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Other: Physical Therapy
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Drug: Methylphenidate
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Primary Outcome(s)
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Balance Evaluation
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Change in gait
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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